Lactation system and method

ABSTRACT

A lactation system is disclosed. Embodiments include at least one extraction mechanism including a compression mechanism and a collection mechanism, and a controller. The compression mechanism can include a plurality of manipulable members, each operably coupled to an actuator and arrangeable circumferentially about a breast of a user such that each member can be actuated to selectively apply pressure to a region of the breast. The collection mechanism can be removably coupleable to the compression mechanism and can comprise a storage compartment to receive and store milk The controller can be operably coupleable to the actuators to cause the members to move according to a movement pattern which can be configured to stimulate the breast to induce the flow of milk from the breast and modulated based on sensor feedback. A wearable garment with an inner structure can be removably coupled to the extraction mechanism. An outer cover can be arrangeable to conceal the extraction mechanism.

CROSS-REFERENCE TO RELATED APPLICATION

The present disclosure claims the benefit of U.S. Provisional PatentApplication No. 62/486,812, filed Apr. 18, 2017, the disclosure of whichis incorporated by reference herein.

TECHNICAL FIELD

Embodiments of the present disclosure relate generally to the field oflactation systems, and more particularly to electrically-powered breastmilk extraction and collection systems.

BACKGROUND

Breast milk is a source of nutrition for many human infants. Breast milkis recommended as a source of nutrition for infants by the World HealthOrganization, the Centers for Disease Control and the American Academyof Pediatrics. In addition to purported health benefits for the nursingmother and child, direct nursing can be a cheap or cost-free method offeeding an infant. In direct nursing, the suckling action of theinfant's mouth can induce the release of oxytocin into the bloodstream.Oxytocin can make the muscles around the mammary glands in the breastscontract, pushing milk into the milk ducts and out through nippleopenings in what is known as the milk ejection reflex. The milk ejectionreflex starts a flow of milk that can be consumed by the infant.

Direct nursing is not always possible or preferable for the mother orchild. Even when mothers are physically capable of nursing, directnursing requires the mother to be available to feed the infant multipletimes per day. In addition, the mother's milk production schedule maynot be optimal for the infant's needs. Breast pumping technology hasenabled mothers to express milk for storage and later feeding. Theinfant can be fed stored milk when needed by the mother, a non-birthingparent, or a caregiver. Milk storage can also provide human breast milkto infants who are unable to receive it from their birth mothers (forexample, in cases of adoption, or undersupply).

Conventional breast pumps rely on a suction mechanism provided by apowered vacuum or hand pump. These pumps generally comprise a roughlyhemi-spherical dome that can be placed over the nipple-areolar complexand a tube or other conduit for expressed milk to be pumped from thebreast to a collection mechanism (such as a bottle, jar, or pouch). Onedisadvantage of conventional breast pumps is the need to disrobesufficiently to expose the nipple. In addition, while hand-powered pumpscan be quiet, they are generally slow, and require a significant amountof physical exertion by the user. Electrically powered breast pumps canbe faster (especially those that are capable of expressing milk fromboth breasts simultaneously), but are often undesirably noisy. Userstherefore often require a private space in which to pump, and aregenerally prevented or distracted from other activities during thepumping process. Furthermore, suction-based pumps can produce up to tentimes the amount of suction that an infant applies while suckling. Thisincreased level of suction often leads to discomfort and pain.

Another method for expressing breast milk is known as manual expression.Instead of the suction action of a pump, the hands are used to applyingpressure to the breast tissue in patterns that induce the flow of milk,which can be collected in a container. In addition to cost, manual (or“hand”) expression can be advantageous because pressure can be appliedselectively to focus on particular areas of the breast. Many women haveparticular areas of the breast that are more productive of milk, andthese areas can change over time. Manual expression is also thought toaffect the nutritional content of the milk. Studies have shown that handexpressed milk has higher fat concentrations than suction pump expressedmilk. This may be due to a retrograde milk flow within the breast. Milkcan flow from the breast, toward the chest wall, before exiting at thenipple-areolar complex. This retrograde flow, which is presumed to beenabled by an infant's suckling pattern, can allow for the backwash ofmilk into the originating alveoli which can carry the higher densitymilk that contains higher fat concentrations.

SUMMARY

Embodiments of the present disclosure provide systems and methods forassisting lactation without requiring application of a vacuum for milkextraction. The system can include elements configured to deliver asequence of manipulations that provide physical compression to thebreast tissue. The manipulations can be modulated (in force, rate,range, or other parameters) in a manner to deliver a desired flow rateof milk. The manipulations can be tailored mimic the behavior of asuckling infant. In embodiments, a sensor can provide a feedback signalto a control mechanism that can modulate actuator(s) to allow automatedadjustment of manipulations in order to provide the desired milkproduction. The system can be integrated within a wearable garment suchthat the user does not need to disrobe during use.

Embodiments of the present disclosure include a lactation system thatcomprises a wearable garment with an inner structure configured to beremovably coupled to at least one insert and an outer cover comprisingpadding and arrangeable to conceal the at least one insert. Each insertcan include a compression mechanism comprising a plurality ofmanipulable members, with each member operably coupled to an actuator.The members can be arrangeable circumferentially about the breast suchthat each member can be actuated to selectively apply pressure to aregion of the breast. The insert can further include a collectionmechanism, operably coupleable to the compression mechanism proximate anipple of the user with a storage compartment to receive and store aflow of milk from the breast. Each insert can further comprise a coverconfigured to separate the insert from the skin of the user.

The controller can be operably coupleable to the actuators to cause themembers to move according to a movement pattern, the movement patterncan be configured to stimulate the breast to induce the flow of milkfrom the breast. The induced flow of milk can be at least partiallyretrograde.

The lactation system can further include a stimulation mechanismcomprising a heating element configured to warm mammary glands withinthe breast to a temperature between 35° Celsius and 42° Celsius. Thestimulation mechanism can comprise a plurality of heating elementsarranged in the outer cover.

In embodiments, the movement pattern can comprise mechanicallycompressing the breast at a pressure between 0 mmHg and 215 mmHg, withan average of between about 20 mmHg and 40 mmHg. The movement patterncan comprise mechanically compressing the breast in a burst patternincluding applying pressure to locations at opposite positions aroundthe breast. The burst pattern can comprise repeatedly applying an upperpressure of about 200 mmHg for about one second and a lower pressure ofabout 20 mmHg for about three to seven seconds, or about two to fourseconds. The burst pattern can be repeated about five times.

Embodiments can include at least one sensor for detecting the flow ofmilk, at least one sensor for detecting the strain or displacement ofthe breast, and at least one sensor for detecting the temperature of themammary glands within the breast. The controller can be configured tomodify the movement pattern based on at least the flow of milk, thestrain or displacement of the breast, and/or the temperature of themammary glands within the breast. In embodiments the movement patterncan be modified by modifying the timing and magnitude of pressureapplied to the locations.

In embodiments, the members can operably coupleable to an annular basethat is arrangeable about the breast proximate the chest wall of theuser. Each of the members can further be rotatable about an individualaxis. In embodiments, each actuator comprises at least one shape-memoryalloy element configured to contract the actuator based on a receivedcontrol signal. The actuators can comprise one or more cables operablycoupled to a series of linkages configured to move axially between thechest wall and the nipple of the user.

In embodiments, an external device can be coupleable to the controllerto provide operational parameters to configure the movement pattern. Theexternal device can comprise a user interface configured to receiveparameters from the user. The user interface can further be configuredto display data received from one or more sensors to the user.

In embodiments, the storage compartment comprises a connection adaptedto interface with an artificial nipple for feeding an infant.

In embodiments a method for collecting milk from a lactating breast caninclude warming mammary glands within the breast to a temperaturebetween 35° Celsius and 42° Celsius, selectively applying pressure to aregion of the breast by controlling a plurality of manipulable membersoperably coupled to actuators in an extraction mechanism and arrangeablecircumferentially about the breast to move according to a movementpattern. The movement pattern can be configured to stimulate the breastto induce a flow of milk from the breast. The milk can be received in astorage compartment of a collection mechanism that is operablycoupleable to the extraction mechanism proximate the nipple of thebreast.

In embodiments, a method for collecting milk from a lactating breast caninclude receiving at a controller a threshold parameter based on a levelof fullness of the breast, such as a strain threshold parameter, andreceiving a signal indicative of a level of fullness of the breastprovided by at least one sensor arranged proximate the breast. Inresponse to detecting the level of fullness of the breast being abovethe threshold parameter the method can include automatically collectingthe milk from the breast by: stimulating a flow of milk from the breastby applying heat to the breast extracting the milk from the breast byselectively applying mechanical pressure to a region of the breast bycontrolling a plurality of manipulable members operably coupled toactuators in an extraction mechanism and arrangeable circumferentiallyabout the breast to move according to a movement pattern configured toinduce a flow of milk from the breast. The flow of milk can be receivedin a storage compartment of a collection mechanism operably coupleableto the extraction mechanism proximate the nipple of the breast.

In embodiments the controller can determine if the collection mechanismis operably coupled to the extraction mechanism before collecting themilk from the breast. In embodiments, user approval can be requestedbefore collecting milk from the breast.

In embodiments, the lactation system can comprise at least oneextraction mechanism including a compression mechanism and a collectionmechanism, and a controller. The compression mechanism can include aplurality of manipulable members, each operably coupled to an actuatorand arrangeable circumferentially about a breast of a user such thateach member can be actuated to selectively apply pressure to a region ofthe breast. The collection mechanism can be removably coupleable to thecompression mechanism proximate the nipple of the user and comprise astorage compartment to receive and store a flow of milk from the breast.The lactation system can further include a wearable garment comprisingan inner structure configured to be removably coupled to the at leastone extraction mechanism and an outer cover comprising padding andarrangeable to conceal the at least one extraction mechanism.

The above summary is not intended to describe each illustratedembodiment or every implementation of the subject matter hereof. Thefigures and the detailed description that follow more particularlyexemplify various embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in considerationof the following detailed description of various embodiments inconnection with the accompanying figures.

FIG. 1A is a plan view depicting a lactation system, according to anembodiment.

FIG. 1B is a plan view depicting a wearable garment, according to anembodiment.

FIG. 1C is a plan view depicting a wearable garment, according to anembodiment.

FIG. 2A is a plan view depicting an extraction mechanism, according toan embodiment.

FIG. 2B is a partial cross-sectional view depicting a lactation system,according to an embodiment.

FIG. 3 is a plan view depicting an insert, according to an embodiment.

FIG. 4A is a plan view depicting a tissue stabilization mechanism,according to an embodiment.

FIG. 4B is a plan view depicting a tissue stabilization mechanism,according to an embodiment.

FIG. 4C is a plan view depicting a tissue stabilization mechanism,according to an embodiment.

FIG. 4D is a plan view depicting a tissue stabilization mechanism,according to an embodiment.

FIG. 4E is a perspective view depicting a tissue stabilizationmechanism, according to an embodiment.

FIG. 4F is a perspective view depicting a tissue stabilizationmechanism, according to an embodiment.

FIG. 5A is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 5B is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 6 is a plan view depicting a compression mechanism, according to anembodiment.

FIG. 7A is a perspective view depicting embodiments of members.

FIG. 7B is a perspective view depicting a manipulable member, accordingto an embodiment.

FIG. 7C is a top view depicting a manipulable member, according to anembodiment.

FIG. 7D is cross-sectional view depicting a manipulable member,according to an embodiment.

FIG. 7E is a plan view depicting a manipulable member, according to anembodiment.

FIG. 8A is a perspective view depicting an actuator, according to anembodiment.

FIG. 8B is a perspective view depicting an actuator, according to anembodiment.

FIG. 9 is a schematic diagram depicting a control system, according toan embodiment.

FIG. 10A is a schematic diagram depicting a movement pattern, accordingto an embodiment.

FIG. 10B is a schematic diagram depicting a movement pattern, accordingto an embodiment.

FIG. 11 is a graph depicting pressure levels of a movement pattern,according to an embodiment.

FIG. 12 is a flowchart depicting a method of initiation extraction,according to an embodiment.

FIG. 13 is a flowchart depicting a method of initiation extraction,according to an embodiment.

FIG. 14 is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 15 is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 16A is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 16B is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 17 is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 18 is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 19A is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 19B is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 20A is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 20B is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 20C is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 21A is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 21B is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 22A is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 22B is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 23A is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 23B is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 24A is a plan view depicting a compression mechanism, according toan embodiment.

FIG. 24B is a perspective view depicting a compression mechanism,according to an embodiment.

FIG. 24C is a plan view depicting a compression mechanism, according toan embodiment.

While various embodiments are amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the claimedinventions to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the subject matter as defined bythe claims.

DETAILED DESCRIPTION

FIGS. 1A-1C are plan views depicting a lactation system 100 according toan embodiment. FIG. 1A depicts an embodiment of a wearable garment 102unfolded to reveal outer cover 104 and inner structure 106 that canreceive one or more inserts 108. Each insert 108 can comprise extractionmechanism 200 and collection mechanism 300. Extraction mechanism 200 canfurther comprise compression mechanism 400. FIG. 1B depicts the wearablegarment 102 of FIG. 1A with the outer cover 104 in place to concealinserts, 108. FIG. 1C depicts wearable garment 102 with inserts 108removed.

Wearable garment 102 can comprise a garment such as a brassiere,camisole, sling, or other form of garment adapted to be worn over atleast a portion of the user's upper torso. Wearable garment 102 cancomprise shoulder straps 110, and can include one or more closuremechanisms such as zippers, hook-and-eye closures, hook and loopfasteners or touch fasteners, buttons, or other closure mechanisms knownin the art. Wearable garment 102 can further comprise padding 112, whichcan be removably or fixedly coupled to outer cover 104 or innerstructure 106, in embodiments. Padding 112 can comprise sufficientlythick, conformable material to obscure inserts 108. The variouscomponents of wearable garment 102 can comprise fabric, or fabric likematerials (such as leather or vinyl). In embodiments, some or all ofwearable garment 102 can comprise stretchable materials such as knitfabrics, or materials comprising elastics, enabling wearable garment 102to conform to the body of the user. While FIGS. 1A-1C depict a wearablegarment including two inserts, embodiments of wearable garment 102 canbe configured to receive a single insert.

System 100 can comprise a stimulation mechanism 114 to provide heatenergy to the breast tissue to achieve a desirable temperature withinthe mammary glands for milk extraction. In embodiments, the desirabletemperature can be between about 35° C. and about 42° C. Stimulationmechanism 114 can comprise one or more heating elements within wearablegarment 102, such as within padding 112, or within insert 108. Thestimulation mechanism 114 can comprise the wearable garment 102 itself,where the wearable garment 102 comprises materials or other featuresenabling capture of body heat from the user, or mechanically orelectrically generated heat provided by various the mechanisms of insert108, discussed below. Other heating methods or elements can also beused, including heating elements external to wearable garment 102itself.

FIG. 2A is an anterior view depicting an embodiment of an insert 108.Extraction mechanism 200 can comprise tissue stabilization mechanism 202which can be arranged proximate the chest wall 20 of the user. Tissuestabilization mechanism 202 can provide static compression to the breasttissue to assist in the milk extraction process and to provide supportand comfort to the user. FIG. 2B is a partial cross-sectional view of aninsert 108, according to an embodiment as fitted over the breast 10 ofthe user.

In embodiments, all or part of insert 108 can be arrangeable withinwearable garment 102 such that the various components of insert 108 areseparated from the skin of the wearer. For example, wearable garment 102can comprise a mesh or fabric layer which can rest between insert 108and the user. In addition and/or in the alternative, insert 108 canfurther comprise an insert cover 116, as depicted in FIG. 3, configuredto separate extraction mechanism 200 from the user. Insert cover 116 canfurther comprise a collection interface 118 for attachment to collectionmechanism 300. Insert cover can be rigid to provide additional support,in embodiments, or flexible to enable conformation with body curvature.

Collection mechanism 300 can be arranged proximate the nipple 30 and beremovably affixed to insert 108 via collection interface 118. Collectionmechanism 300 can comprise connection 302, and storage compartment 304.Storage compartment 304 can comprise a pouch, sac, bottle, or othercollection receptacle for collecting expressed breast milk. Storagecompartment 304 can comprise a sterilizable material (such as latex orsilicone rubber). Connection 302 can be configured to engage with acover, and/or a teat (artificial nipple) and associated fixation deviceto enable the feeding of an infant from the storage compartment 304.Connection 302 can therefore present threads, or other mechanism forattachment to interface 118.

FIGS. 4A-4F depict various embodiments of a tissue stabilizationmechanism 202 that can be arranged circumferentially about the breast 10of the user. Tissue stabilization mechanism 202 can comprise one or morefeatures to enable removable fixation of insert 108 within wearablegarment 102. As can be seen in FIGS. 4A and 4B, tissue stabilizationmechanism 202 can comprise an elongate body 204, and one or moresecurement mechanisms 206. Body 204 can comprise a multi-layeredmaterial to provide rigidity and reduce the degrees of freedom of thebreast tissue proximate the chest wall 20 during active compression asprovided by compression mechanism 400 (discussed in more detail below).Securement mechanisms 206 can comprise buttons, hook-and-loop closures,tabs, slots, or other features enabling opposite ends of the body 204 tobe joined, removably fixing tissue stabilization mechanism 202 to thebreast 10 of the user. In embodiments, securement mechanism 206 can beadjustable, enabling varied morphology, fits, and assembly/disassemblyof wearable garment 102 and insert 108. FIG. 4C is a side view depictingan embodiment of the tissue stabilization mechanism arranged around thebreast 10 of a user, proximate the chest wall 20.

FIG. 4D is an anterior view depicting an alternative embodiment of atissue stabilization mechanism 202′. Tissue stabilization mechanism 202′can comprise a plurality of plates 208, that can be joined with elasticor spring members 210 for arrangement about the breast of the user.Spring members 210 can draw plates 208 radially inward, providing astatic compress ion of the breast tissue proximate the chest wall 20.FIGS. 4E and 4F are perspective views of yet another embodiment oftissue stabilization mechanism 202″. Tissue stabilization mechanism 202″can comprise a one-way valve 214 enabling air to escape when opened.This can result in a slight pressure to create a firm fit around thebreast tissue.

FIGS. 5A and 5B are perspective views depicting an embodiment of acompression mechanism 400. Compression mechanism 400 can be arrangedaround the breast 10 of the user, posterior to the nipple-areolarcomplex 40. Compression mechanism 400 can comprise a plurality ofmanipulable members 402, operably coupled to one or more actuators 404.Actuators 404 can be electrically coupleable to, and powerable by apower supply 406 and/or a control system 500.

Power supply 406 can be a direct-current power supply. Power supply 406can comprise a battery housing configured to receive one or morealkaline or rechargeable battery cells. Power supply 406 can furthercomprise piezoelectric, solar, thermal, or other energy capturemechanisms configured to charge battery cells or to directly poweractuators 404. In embodiments, power supply 406 can be coupleable towearable garment 102, or external to the other components of system 100.In embodiments, power supply 406 can comprise a contoured housingadapted for comfortable arrangement on or near the body of the user.Those of ordinary skill in the art will appreciate that power supply 406can comprise any format or mechanisms capable of providing power toactuators 404 to move members 402.

As can be seen in FIG. 6, members 402 can be radially spaced such thatwhen compression mechanism 400 is arranged proximate the nipple-areolarcomplex 40, the members can contact the tissues laterally, medially,superiorly, and inferiorly. The quantity of members can vary inembodiments based on the size of the members 402 and the sizerequirements for compression mechanism 400. Members 402 can bepositioned proximate the chest wall, and extend toward, but not reach,the nipple-areolar complex 40. In embodiments, static ring 408 cancomprise part or all of tissue stabilization mechanism 202. Inembodiments, the number of members 402 can also be customized by theuser. Members 402, with or without corresponding actuators 404 can beremovably coupled to a static ring 408, such that members of differentsizes, shapes and/or materials can be chosen to provide a preferred fitor action for the user. For example, members 402 that are arranged inlateral, medial and inferior positions can be longer than members 402 inan arranged superiorly to the breast 10.

Each member 402 can comprise a generally petal or spoon-shaped form,adapted to enable a concave surface of the member 402 to conform to theconcave surface of the breast 10 of the user. FIG. 7A depicts a varietyof embodiments of members 402 that can conform to different sizes andconfigurations of body curvature. FIGS. 7B-E are plan and perspectiveviews depicting a member 402, according to an embodiment. The angle oftake-off or curvature of the members 402 can be determined based onactual breast geometry. For example, members 402 can be custom fittedfor a user based on measurements taken from the individual user, forexample by direct measurement, or 2/3D dimensional imaging technology.Members 402 can comprise rigid, flexible, or conformable materials suchas plastic, silicone, urethane, or materials. The various embodiments ofcompression mechanism 400 depicted herein provide further examples ofmembers 402 that can be used.

FIGS. 8A and 8B are perspective views depicting embodiments of a member402 and actuator 404. FIG. 8A depicts actuator 404 in a neutral state,FIG. 8B depicts actuator 404 in a contracted state. Actuators 404 cancomprise shape-memory alloy (SMA) actuators, servos, cable-drivenlinkages, or other mechanisms enabling members 402 to move in a cyclicfashion to provide active compression of the breast tissue. Actuators404 can comprise one or more cables 410, which can be SMA wires. Wherecables 410 comprise shape-memory materials, cables 410 can vary inlength in response to an electrical current, resulting in contraction ofactuator 404, and radially inward movement and rotation of member 402.Other methods of contracting actuator 404 can be used. For example,cables 410 can be at least partially wound to a bobbin or spindle, whichcan be rotated to shorten or lengthen cable 410 as required. Actuator404 can further comprise a plurality of stabilization plates 412. Inembodiments, actuators 404 can provide mechanical compressive pressureto the breast tissue between about 0 mmHg and 215 mmHg, with an averagebetween about 25 mmHg and 40 mmHg. The mechanical compressive pressurecan be applied circumferentially (around the tissue), radially (pushinginward toward the tissue, or a combination).

Actuators 404 can be electrically coupled to a control system 500, anembodiment of which is depicted in FIG. 9. Control system 500 cancomprise a controller 502, one or more sensors 504, and input/outputinterface 506. Controller 502 can be configured to modulate anelectrical current or other signal in order to induce actuators 404 tomove members 402 in one or more patterns adapted to induce theexpression of breast milk through mechanical compression of the breasttissue. Controller 502 can also provide modulation signals tostimulation mechanism 114 to produce heat. In embodiments, each actuator404 can receive a separate signal from controller 502, enablingindividual actuator control. In other embodiments, all actuators 404 canbe modulated with a single signal, or groups (such as opposing pairs) ofactuators 404 can be modulated together. Actuators 404 can bewater-proof or water-resistant, in embodiments. For example, actuators404 can comprise waterproof components, or can be treated with aflexible waterproofing finish material.

Input/output interface 506 can comprise a wired or wireless interfacefor communication with an external device 508 such as a computer system,tablet, smart phone, mobile device, or the like. External device 508 cancomprise user interface 510. User interface 510 can receive user inputsincluding control parameters and provide user outputs regardingconfiguration and status of lactation system 100, such as sensor data.User interface 510 can comprise a mobile application, web-basedapplication, or any other executable application framework. Userinterface 510 can reside on, be presented on, or be accessed by anycomputing devices capable of communicating with input/output interface506, receiving user input, and presenting output to the user.

Actuators 404 and stimulation mechanism 114 can modify various physicalcharacteristics 512 detectable by sensors 504. Sensors 504 can compriseone or more temperature sensors to detect the temperature within andaround lactation system 100. Sensors 504 can comprise one or morepressure sensors to detect an actual amount of force being applied tothe breast tissue by members 402. Sensors 504 can comprise strainsensors to detect force applied to the members 402 by the breast tissue.In embodiments, actuators 404 can provide strain, pressure, or otherdata. Sensors 504 can comprise one or more accelerometers to detect themovement of members 402, or the movement, posture, or othercharacteristic of the user. Sensors 504 can comprise one or more flowmeters, volume sensors, or weight sensors to detect the amount of milkflowing into, or stored within, collection mechanism 300. Control systemcan further comprise a safety override 514 to enforce one or more safetylimitations such that members 402 will not be induced to move in amanner that is potentially harmful to the user.

Based on input parameters and sensor data, control system 500 cancontrol the position and movement of members 402 according to a varietyof different patterns to induce the flow of breast milk. In oneembodiment, depicted schematically in FIG. 10A, members 502 can becontrolled such that opposing pairs (or groups) of members are inducedto provide mechanical compression in synchronized pairs. For example, Aand C can compress inward, while B and D remain fixed. The alternatingpattern of compressing and fixed members 402 can enhance the compressiveforce by limiting the ability of the breast tissue to be moved away fromthe compressing members 402. FIG. 10B depicts another embodiment of amovement pattern using six members 402, the pair of members labeled Acan be moved first, followed by B, and C. Control system 500 can furthercontrol members to produce a cyclic flattening and lengthening of thenipple 30 of the user, which can be in a manner tailored to mimic thebehavior of a suckling infant.

Other patterns of movement can be produced. For example, in oneembodiment, compression can be effected using a burst pattern, includingat least two peaks in compression, though other numbers of peaks can beused, for example, five or more. The peaks in compression can occurabout every two to four seconds and have a duration of less than aboutone second. In embodiments, the burst patterns can occur every three toseven seconds. The burst pattern can include cycling through individualmembers 402 or pairs of members, such that a first set of members, canperform two or more peaks, and after a break period (of about threeseconds), a second set of members, can perform two or more peaks, and soforth. The pressure applied during peaks can be up to about 200 mmHg,though other values can be used, for example about 40 mmHg. The pressureapplied between peaks can be 0 mmHg, or another value such as around 20mmHg. FIG. 11 is a graph depicting peak and mean pressures that can beapplied, in embodiments. The burst pattern consisting of periods of highand low pressure can enable the beneficial retrograde flow of milkwithin the breast tissue.

The patterns and force of compression can be modified based on inputparameters received through user interface 510. For example, userinterface 510 can enable the user to assign one or more members 402 toactivation groups (the members of which can be moved synchronously). Theuser interface 510 can receive parameters indicating the number of peaksper cycle, an upper pressure target, a minimum pressure target (to beused between peaks, or when the activation group is not moving), aduration of the peaks, a time period between peaks, and the order inwhich each activation group is to be used.

Control system 500 can further use the data from sensors 504 todetermine optimal levels and locations of compressive force to use inorder to maximize the amount and speed of milk extraction. For example,control system 500 can identify an area of a breast 10 that, whencompressed, results in increased milk flow. The movement pattern canthen be modified to provide more focus on that area. In another example,control system 500 may identify an area of a breast 10 (or even which ofthe user's breasts) has the most potential for milk extraction in orderto direct the compressive force. In one embodiment, control system 500can automatically begin extraction at specified times, or when thephysical characteristics indicate that extraction would be appropriate.For example, it may be desirable to only extract milk when the user isat least partially upright, but is not in motion (i.e., sitting orstanding still). The control system 500 can also verify that collectionmechanism 300 is appropriately connected and that storage compartment304 is has available storage capacity before beginning. Milk extractioncan therefore be performed automatically without intervention by theuser. Milk extraction sessions can be about twenty minutes in duration,though longer and shorter time periods can be used. The duration of eachextraction session can be determined by an input parameter, or modifiedbased on sensed milk extraction.

FIG. 12 is a flowchart depicting a method 1000 for automaticallybeginning milk extraction, according to an embodiment. At 1002, straindata can be received from sensors 504. The strain can be checked againsta threshold at 1004. The threshold can be a static threshold, orconfigurable by the user. In addition, different strain thresholds canbe maintained for different areas of the breast, based on the locationof strain sensors. Strain sensor data can therefore be used to determinethat milk extraction is appropriate. If, at 1004, the strain is notabove the threshold, control can iterate back to 1002 to monitor thestrain sensor data. If the strain is detected to be above the threshold,and automated start is enabled (for example, via a user configurationsetting), the components of lactation system 100 can be checked forreadiness at 1008. If automated start is not enabled, a request can bemade to the user for approval to initiate extraction at 1010. The usercan be alerted to the request via external device 508. In embodiments,one or more components of insert 108 can be configured with hardwareenabling it to beep, vibrate, light up, or provide other feedback to theuser.

At 1008, the various components of system 100 can be checked to verifythat the system is capable of safely extracting milk. For example, oneor more sensors 504 can detect that collection mechanism 300 iscorrectly engaged and has available storage capacity. If the componentsare not ready, the user can be alerted at 1012. At 1014, if the usersuccessfully remedies the problem, extraction can being at 1016. If, at1008, all component systems are ready, control can proceed directly to1016.

At 1014, if the user does not successfully remedy the problem (forexample, if the user cancels the request, or a maximum time is reached),the current session can end at 1018, and control can return to 1002 todetect strain levels after a time delay at 1020.

FIG. 13 is a flowchart depicting a method 2000 for controlling a milkextraction session, according to an embodiment. At 2002, a session canbegin. The session can be started manually by user request, orautomatically. At 2004, the initial movement patterns can be set. Themovement patterns can be set based on previously stored configurations,hard coded, or received as input parameters from the user at the startof the session. At 2006, milk flow data from sensors 504 can bemonitored. If, after a certain amount of time, insufficient milk flow isdetected at 2008, the movement patterns can be modified at 2010.Movement patterns can be modified to change the amount of pressureexerted by members 402. The pressure change can be localized, such thatpressure is increased in some areas and decreased in others. Themovement patterns can further be changed to modify the timing of burstpatterns. One or more modifications can be made at one time, and inembodiments, the sequence of movement patterns to attempt can beconfigured by the user. After the movement patterns have be modified,control can return to 2006 to continue to monitor the milk flow. If themilk flow is sufficient, the session can continue at 2012. Inembodiments, the current movement patterns can be saved for use infuture sessions, or for data gathering purposes.

FIGS. 14-24 depict various alternative embodiments of compressionmechanism 400, including alternative arrangements and configurations ofmembers 402 and actuators 404. Compression mechanism 400 can providemechanical compression provided by one or more of a worm gear system, apulley tensioning system, a cable tensioning weave, and/or a linkagesystem that translates rotational and linear motion.

FIG. 14 is an anterior view depicting a winged embodiment of compressionmechanism 400. Members 402 can comprise two-part wings and be operablycoupled to juxtaposed electromagnetic actuators. When energized,electromagnetic actuators 404 can be mutually repelled, such thatmembers 402 are urged radially inward. In embodiments, members 402 andactuators 404 can be arranged such that electromagnetic attractionresults in inward pressure. FIG. 15 is an side view depicting a sleevebased compression mechanism 400. Members 402 be arranged within thesleeve to provide axially forward pressure to breast 10.

FIG. 16A is an anterior view depicting a linear bearing basedembodiment. Linear bearings can be arranged along one or more circularmagnetic tracks. Members 402 can be operably coupled to the bearing suchthat they move circumferentially around the breast when the track ismagnetically activated. FIG. 15B is a perspective view depicting anembodiment where magnetic actuators can urge members along/into eachother.

FIG. 17 is a perspective view depicting a cam-projection basedembodiment. Members 402 can comprise cam-like projections inward fromcircumferential a track.

As depicted in FIG. 18, actuators 404 can comprise tightenabletensioners (such as cables). Tensioners can be tightenedcircumferentially to shift members 402 together and/or into/across eachother via tracks/slides results to result in a decrease in diameter.

FIGS. 19A and 19B are side views depicting a ring based embodiment.Members 402 can comprise disc, rings, or plates, which can be pulledaxially toward or away from the chest wall by actuator cables. Theinterlocking/separable members 402, can move individually or insynchrony about a z-axis (normal to the chest wall). Members 402 can be360 degrees or less, and circular, oblong, or oval. Actuators 404 cancomprise tensioner cables and/or rods. Two or more members can beconnected to cables that are embedded into material, pockets, and/ortracks, enabling coverage of cables and therefore avoidance of pinchpoints while in motion. Rotational movement about the z-axis can allowfor cables to twist and pull solid bodies in toward center of breast. Inan embodiment, members 402 can be interlocked to enable dual-motion/ordual-motion/rotation.

FIGS. 20A-20C depict an additional tension cable embodiment. Members 402can be manipulated by cables 410 of actuators 404 to move betweenrelaxed and compressed states. While, as depicted tightening of cables410 results in members 402 moving into a compressed state, members 402and cables 410 can be arranged such that tightening results inrelaxation of members 402.

FIGS. 21A and 21B depict a spherical slider embodiment. Members 402 canbe semi-spherical plates which can be operably coupled to a track forcircumferential movement around breast tissue.

FIGS. 22A and 22B depict a finger-like embodiment. Members 402 cancomprise segmented fingers. The fingers can be actuated by cables,linkages, or individual motors, in embodiments. The fingers can beoperably coupled to a ring, which can also comprise collection mechanism118.

FIGS. 23A and 23B depict rocker based embodiments. Members 402 canrockers that can be urged by multi-phased rocker arms for compression.Members 402 can each comprise individual rotation points, and can beactuated via electromagnets, cables, or other actuation methodsdiscussed herein.

As depicted in FIGS. 24A-24C, actuators 404 can comprise multiplelayered linkage systems to synchronize the compressive phase betweengroups of actuators 404. The corresponding members can therefore belocked stationary, or moving based on actuation. In embodiments, thelinkage systems can comprise four-bar linkages. The bars of the linkagesystem can be members 402. As depicted in FIG. 24A, a collar 420 can bedriven along a shaft 422 by a motor 424 or other means. Shaft 422 can beflexible, fully rigid, or partially rigid. Members 402 can be attachedat a hinge point 426. Movement of collar 420 along shaft can induce aclamping action in members 402. Multiple actuators 404 can be providedand arranged radially around the breast 10.

Actuators 404 can comprise shapeable material inserts to fit to breastsurface, thereby reducing clearance between the device starting position(relaxed or compressed) and the corresponding active position(compressed or relaxed). Actuators 404 can comprise ball and/or pivotjoint connections. This can enable a more comfortable fit, due to theadditional degrees of freedom. Actuators 404 can be embedded in wearablegarment 102, and/or polymer materials within inserts 108. Actuators canbe operably coupled to motor 424 by a tiered gear system which canprovide synchrony between each group of actuators.

Embodiments of the present disclosure can enable mothers to extractbreast milk discreetly, and can mimic many of the physiologic mechanismsthat occur during breastfeeding. Many infants do not exclusively receivebreast milk for nutrition as recommended by the World HealthOrganization, the Center for Disease Control and the American Academy ofPediatrics because the current system of breast pumping for workingmothers presents significant barriers. These barriers account for thesecond most common reason for women to stop breast pumping. This deviceaims to improve the work-life balance for women so that they cancontinue to excel at work while still providing breast milk to theirinfants. Additionally, this device aims to increase the proportion ofinfants who are exclusively nourished with breast milk at 6 months ofage.

In contrast to traditional breast pumps, embodiments use warmth tostimulate, and can provide mechanical compression as a mechanism ofexpression. Embodiments can mimic the infant interaction at the nipplewhile avoiding reliance on a suction mechanism for expression.Embodiments further provide for configurable parameters for compressionforce including specific patterns and locations of compression. Becauseembodiments can be integrated into a wearable garment they can remaindiscrete and allow for the hands-free extraction of breast milk.

Embodiments of the present disclosure include a method for collectingmilk from a lactating breast, the method comprising receiving at acontroller, a strain threshold parameter; monitoring, with at least onesensor arranged proximate the breast, a strain or displacement of thebreast; in response to detecting the strain or displacement of thebreast being above the threshold parameter, automatically collecting themilk from the breast by selectively applying pressure to a region of thebreast by controlling a plurality of manipulable members operablycoupled to actuators in an extraction mechanism and arrangeablecircumferentially about the breast to move according to a movementpattern, the movement pattern configured to stimulate the breast toinduce a flow of milk from the breast; and receiving the flow of milk ina storage compartment of a collection mechanism operably coupleable tothe extraction mechanism proximate the nipple of the breast. The methodcan further comprise determining if the collection mechanism is operablycoupled to the extraction mechanism before collecting the milk from thebreast.

In an embodiment a lactation system can comprise at least one extractionmechanism comprising a compression mechanism comprising a plurality ofmanipulable members, operably coupled to actuators and arrangeablecircumferentially about a breast of a user such that each member can beactuated to selectively apply pressure to a region of the breast, and acollection mechanism, removably coupleable to the compression mechanismproximate the nipple of the user and comprising a storage compartment toreceive and store a flow of milk from the breast; and a controlleroperably coupleable to the actuators to cause the members to moveaccording to a movement pattern, the movement pattern configured tostimulate the breast to induce the flow of milk from the breast.

An embodiment further comprises a wearable garment, the wearable garmentcomprising: an inner structure configured to be removably coupled to theat least one extraction mechanism; and an outer cover comprising paddingand arrangeable to conceal the at least one extraction mechanism.

An embodiment further comprises a stimulation mechanism comprising aheating element configured to warm mammary glands within the breast to atemperature between 35° Celsius and 42° Celsius. In one embodiment, thestimulation mechanism comprises a plurality of heating elements arrangedan outer cover arrangeable to conceal the at least one extractionmechanism.

In an embodiment, the actuators comprise one or more cables operablycoupled to a series of linkages configured to move axially between thechest wall and the nipple of the user.

The members can be operably coupleable to an annular base that isarrangeable about the breast proximate the chest wall of the user. Eachof the members is rotatable about an individual axis. In an embodiment,the movement pattern comprises mechanically compressing the breast at apressure between 0 mmHg and 215 mmHg. The movement pattern can comprisemechanically compressing the breast at a pressure between 20 mmHg and 40mmHg.

It should be understood that the individual steps used in the methods ofthe present teachings may be performed in any order and/orsimultaneously, as long as the teaching remains operable. Furthermore,it should be understood that the apparatus and methods of the presentteachings can include any number, or all, of the described embodiments,as long as the teaching remains operable.

In one embodiment, the control system 500 and/or its components orsubsystems can include computing devices, microprocessors, modules andother computer or computing devices, which can be any programmabledevice that accepts digital data as input, is configured to process theinput according to instructions or algorithms, and provides results asoutputs. In one embodiment, computing and other such devices discussedherein can be, comprise, contain or be coupled to a central processingunit (CPU) configured to carry out the instructions of a computerprogram. Computing and other such devices discussed herein are thereforeconfigured to perform basic arithmetical, logical, and input/outputoperations.

Computing and other devices discussed herein can include memory. Memorycan comprise volatile or non-volatile memory as required by the coupledcomputing device or processor to not only provide space to execute theinstructions or algorithms, but to provide the space to store theinstructions themselves. In one embodiment, volatile memory can includerandom access memory (RAM), dynamic random access memory (DRAM), orstatic random access memory (SRAM), for example. In one embodiment,non-volatile memory can include read-only memory, flash memory,ferroelectric RAM, hard disk, floppy disk, magnetic tape, or opticaldisc storage, for example. The foregoing lists in no way limit the typeof memory that can be used, as these embodiments are given only by wayof example and are not intended to limit the scope of the disclosure.

In one embodiment, the system or components thereof can comprise orinclude various modules or engines, each of which is constructed,programmed, configured, or otherwise adapted to autonomously carry out afunction or set of functions. The term “engine” as used herein isdefined as a real-world device, component, or arrangement of componentsimplemented using hardware, such as by an application specificintegrated circuit (ASIC) or field-10 programmable gate array (FPGA),for example, or as a combination of hardware and software, such as by amicroprocessor system and a set of program instructions that adapt theengine to implement the particular functionality, which (while beingexecuted) transform the microprocessor system into a special-purposedevice. An engine can also be implemented as a combination of the two,with certain functions facilitated by hardware alone, and otherfunctions facilitated by a combination of hardware and software. Incertain implementations, at least a portion, and in some cases, all, ofan engine can be executed on the processor(s) of one or more computingplatforms that are made up of hardware (e.g., one or more processors,data storage devices such as memory or drive storage, input/outputfacilities such as network interface devices, video devices, keyboard,mouse or touchscreen devices, etc.) that execute an operating system,system programs, and application programs, while also implementing theengine using multitasking, multithreading, distributed (e.g., cluster,peer-peer, cloud, etc.) processing where appropriate, or other suchtechniques. Accordingly, each engine can be realized in a variety ofphysically realizable configurations, and should generally not belimited to any particular implementation exemplified herein, unless suchlimitations are expressly called out. In addition, an engine can itselfbe composed of more than one sub-engines, each of which can be regardedas an engine in its own right. Moreover, in the embodiments describedherein, each of the various engines corresponds to a defined autonomousfunctionality; however, it should be understood that in othercontemplated embodiments, each functionality can be distributed to morethan one engine. Likewise, in other contemplated embodiments, multipledefined functionalities may be implemented by a single engine thatperforms those multiple functions, possibly alongside other functions,or distributed differently among a set of engines than specificallyillustrated in the examples herein.

Various embodiments of systems, devices, and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the claimed inventions. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, configurations and locations, etc. have been described for usewith disclosed embodiments, others besides those disclosed may beutilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize thatembodiments may comprise fewer features than illustrated in anyindividual embodiment described above. The embodiments described hereinare not meant to be an exhaustive presentation of the ways in which thevarious features may be combined. Accordingly, the embodiments are notmutually exclusive combinations of features; rather, embodiments cancomprise a combination of different individual features selected fromdifferent individual embodiments, as understood by persons of ordinaryskill in the art. Moreover, elements described with respect to oneembodiment can be implemented in other embodiments even when notdescribed in such embodiments unless otherwise noted. Although adependent claim may refer in the claims to a specific combination withone or more other claims, other embodiments can also include acombination of the dependent claim with the subject matter of each otherdependent claim or a combination of one or more features with otherdependent or independent claims. Such combinations are proposed hereinunless it is stated that a specific combination is not intended.Furthermore, it is intended also to include features of a claim in anyother independent claim even if this claim is not directly madedependent to the independent claim.

Moreover, reference in the specification to “one embodiment,” “anembodiment,” or “some embodiments” means that a particular feature,structure, or characteristic, described in connection with theembodiment, is included in at least one embodiment of the teaching. Theappearances of the phrase “in one embodiment” in various places in thespecification are not necessarily all referring to the same embodiment.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of Section 112, sixth paragraph of 35 U.S.C. are not tobe invoked unless the specific terms “means for” or “step for” arerecited in a claim.

What is claimed is:
 1. A lactation system comprising: a wearable garmentcomprising an inner structure configured to be removably coupled to atleast one insert and an outer cover arrangeable to conceal the at leastone insert; a stimulation mechanism comprising a heating elementconfigured to warm mammary glands within a breast of a user to atemperature between 35° Celsius and 42° Celsius; each at least oneinsert comprising: a compression mechanism comprising a plurality ofmanipulable members, each of the plurality of manipulable membersoperably coupled to an actuator and arrangeable circumferentially aboutthe breast such that each of the plurality of manipulable members can beactuated to selectively apply pressure to a region of the breast, and acollection mechanism, operably coupleable to the compression mechanismconfigured to be proximate a nipple of the user and comprising a storagecompartment to receive and store a flow of milk from the breast; and acontroller operably coupleable to the actuators to cause the pluralityof manipulable members to move according to a movement pattern, themovement pattern configured to stimulate the breast to induce the flowof milk from the breast, wherein the movement pattern comprisesmechanically compressing the breast in a burst pattern comprisingapplying pressure to locations at opposite positions around the breast,and wherein the burst pattern comprises repeatedly applying an upperpressure of about 200 mmHg for about one second and a lower pressure ofabout 20 mmHg for about three to seven seconds.
 2. The lactation systemof claim 1, wherein the movement pattern comprises mechanicallycompressing the breast at a pressure between 0 mmHg and 215 mmHg.
 3. Thelactation system of claim 1, wherein the burst pattern comprisesrepeatedly applying the lower pressure for about two to four seconds. 4.The lactation system of claim 1, wherein the movement pattern comprisesrepeating the burst pattern at least five times.
 5. The lactation systemof claim 1, further comprising at least one sensor for detecting theflow of milk and wherein the controller is configured to modify themovement pattern based on at least the flow of milk.
 6. The lactationsystem of claim 1, wherein each actuator comprises at least oneshape-memory alloy element configured to contract the actuator based ona received control signal.
 7. The lactation system of claim 1, furthercomprising an external device coupleable to the controller to provideoperational parameters to configure the movement pattern.
 8. Thelactation system of claim 7, wherein the external device comprises auser interface configured to: receive parameters from the user anddisplay data received from one or more sensors to the user.
 9. Thelactation system of claim 1, wherein the storage compartment comprises aconnection adapted to interface with an artificial nipple for feeding aninfant.